NCT06380829

Brief Summary

This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability. Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 19, 2024

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • To asses Turkish validity and reliability of Self-Care Assessment Scale for Children with CP aged 3-6 years

    This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability. The scale includes 24 items to question the child's self-care skills, such as independent nutrition, eating, being able to express himself while meeting his basic needs, toileting, dressing, washing hands and face, brushing teeth, cleaning his nose and expressing himself when he is sleepy, in accordance with his age. The scale is a 5-point Likert type, and each item is scored between 1-5, from "Always (independent)" to "Never (completely dependent)". In the scale, the 4th, 8th, 17th, 23rd scale items are reversed to obtain the total scale score. A minimum of 24 and a maximum of 120 points can be obtained from the scale. A high score from the scale indicates that the child with CP has good self-care skills.

    six month from the beginning of the study

Interventions

Self-Care Assessment Scale for Children with CP aged 3-6 years - Parent Form (SPÇÖS-EF): A draft scale named SPÇÖS-EF was prepared by the researchers, using the literature, to determine the self-care status of children with cerebral palsy aged 3-6.

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with CP between the ages of 3-6

You may qualify if:

  • Being between 3-6 years old (36-72 months) living with their parents

You may not qualify if:

  • be at least literate He/she was able to speak and understand Turkish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bircan Kahraman Berberoğlu

Aydin, 0900, Turkey (Türkiye)

Location

Related Publications (1)

  • Kahraman Berberoglu B, Calisir H. The effect of structured supportive approach based on Kolcaba's comfort theory applied to parents of children with cerebral palsy on child's comfort, quality of life, and parent's self-efficacy: A randomised controlled trial. J Pediatr Nurs. 2024 Mar-Apr;75:e65-e74. doi: 10.1016/j.pedn.2023.12.032. Epub 2024 Jan 20.

    PMID: 38246818BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • BIRCAN KAHRAMAN BERBEROĞLU, PHD

    Aydın Adnan Menderes Univercity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research asistant

Study Record Dates

First Submitted

April 19, 2024

First Posted

April 24, 2024

Study Start

June 5, 2023

Primary Completion

December 5, 2023

Study Completion

February 10, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations